NEUROSTIMULATOR (ENS)
FDA premarket approval P970004/S173 · decided 2014-06-10
Approval details
- PMA number
- P970004
- Supplement
- S173
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEUROSTIMULATOR (ENS)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2014-05-12
- Decision date
- 2014-06-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ACCEPTANCE OF MANUFACTURING CHANGES/PROCESS CHANGES AT TWO LOCATIONS INTENDED TO IMPROVE THE MANUFACTURING PROCESSES TO INCREASE THE ASSURANCE THAT THE MODEL 3531VERIFY ENS AND THE MODEL 3537 CONTROLLER WILL PERFORM AS EXPECTED.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |